Agoviz Tablets Usage And Safety
Dosage
Agomelatine
Side Effects
Psychiatric disorders Common: Anxiety Uncommon: Agitation and related symptoms (such as irritability and restlessness), Aggression Nightmares, Abnormal dreams, confusional state Rare: Mania/hypomania, Hallucinations Frequency not known: Suicidal thoughts or behavior Nervous system disorders Common: Headache, Dizziness, Somnolence, Insomnia, Migraine Uncommon: Paraesthesia, Restless leg syndrome Rare: Akathisia Eyes disorders Uncommon: Blurred vision Ear and vestibular system disorders Uncommon: Tinnitus Gastrointestinal Disorders Common: Nausea, Diarrhoea, Constipation, Abdominal pain, vomiting Hepato- biliary disorders Common: Increased ALAT and/or ASAT Rare: Hepatitis, Increased gamma-glutamyltransferase (GGT) (>3 times the upper limit of the normal range), Increased alkaline phosphatase (>3 times the upper limit of the normal range), Hepatic failure Jaundice Skin and subcutaneous tissue disorders Common: Hyperhidrosis Uncommon: Eczema, Pruritus, Urticaria Rare: Erythematous rash, Face edema and angioedema Musculoskeletal and connective tissue disorders Common: Back pain General disorders and administration site conditions Common: Fatigue Renal and Urinary disorders Rare: Urinary retention
Drug Interactions
Potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin , moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin ) .
Indication
Treatment of major depressive disorder in adults including prevention of relapse.
When not to Use
? Hypersensitivity to Agomelatine ? Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 times the upper limit of normal. ? Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin)